Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!Job DetailsDirector, Regulatory Affairs CMC – BiologicsAbout the RoleWe are seeking an experienced Director, Regulatory Affairs CMC – Biologics to provide strategic and operational regulatory leadership across the biologics product lifecycle. This role is ideal for a senior regulatory professional who enjoys leading complex CMC submissions, advising clients, and partnering closely with cross‑functional teams.Reporting to the Director, Regulatory Affairs – CMC, you will have overall responsibility for CMC aspects of regulatory submissions, regulatory strategy, health authority interactions, and post‑approval lifecycle management.What You’ll DoAs a senior leader and subject‑matter expert, you will:Partner with the management team to help direct and support the businessLead and manage all CMC regulatory activities for biologics programs across the product lifecycleOversee CMC components of regulatory submissions, including CTAs, INDs, NDSs, NDAs, BLAs, and NSNsAct as the CMC regulatory SME, advising project teams on strategy, risk, and key decision pointsSupport and participate in health authority interactions and agency meetingsManage post‑approval changes and lifecycle management activitiesPartner with internal teams, CROs, CMOs, clients, and regulatory agencies to deliver high‑quality outcomesServe as a trusted client contact, supporting scoping, quoting, deliverable review, and invoice reconciliationManage key client accounts to ensure deliverables, timelines, and expectations are metLead multiple projects simultaneously, prioritizing effectively to meet tight timelines and budgetsStay current with evolving global regulations and guidance to provide up‑to‑date regulatory adviceLead, mentor, and develop team members through clear delegation, coaching, and planningMaintain and contribute to internal SOPs and job aidsWhat You Bring:Education & ExperiencePost‑secondary degree in biological, pharmaceutical, chemical, engineering sciences, or a related field10–15 years of direct CMC Regulatory Affairs experience, with a strong focus on biologicsHands‑on experience authoring and/or reviewing Module 3, and leading or supporting health authority interactionsProven leadership experience and/or regulatory consulting backgroundTechnical ExpertiseDirect experience with a range of submission types, including:Writing/reviewing Module 3 and Module 2.3 for CTAs, INDs, NDSs, NDAs, and BLAsDrug substance and drug product CMC sectionsControl strategy, specifications, stability, analytical methods, validation, comparability, and viral safetyStrong understanding of Health Canada and FDA CMC regulatory requirementsKnowledge of Environment Canada New Substances RegulationsSkills & StrengthsStrong project and people leadership skillsStrategic thinker with practical problem‑solving ability for complex regulatory issuesComfortable leading in a cross‑functional, multidisciplinary environmentHighly organized, detail‑oriented, and dependable with deadlinesExcellent written and verbal communication skillsStrong presentation and stakeholder‑management skillsProficiency with Microsoft Word, Excel, PowerPoint, and other Office toolsWhy Join UsWork on innovative biologics programs across the full product lifecyclePlay a visible leadership role with real strategic impactCollaborate with experienced, science‑driven teams and global clientsBalance hands‑on regulatory work with client engagement and team leadership#LI-SS1What Cencora offersWe provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.Full time.Equal Employment OpportunityCencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedAccessibility PolicyAmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.Salary Range*$135,200 CAD - 208,340 CADThis posting is intended to fill an existing vacancy for our Director, Regulatory Affairs CMC - Biologics role.Affiliated Companies: Affiliated Companies: Innomar Strategies
